• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Incontinence (1928); Urinary Frequency (2275); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient experienced prolapse and rectocele, with symptoms of urinary incontinence, nocturia, hesitancy, incomplete bladder emptying and dyspareunia. It was reported that the patient underwent a vaginal hysterectomy and pelvic floor repair on (b)(6) 2007 and mesh and another mesh were implanted. It was reported that she underwent a posterior pelvic floor repair procedure on (b)(6) 2010 to repair her anterior wall prolapse and rectocele and mesh was implanted. It was reported that the patient underwent pelvic floor repair on (b)(6) 2011 and on (b)(6) 2016. It was reported that she experienced spraying during urination, frequency, nocturia, urgency, urge incontinence, back, groin and pelvic pain, constipation, overactive bladder, sui, incomplete bladder emptying, dyspareunia and mesh retraction. It was reported that she underwent two surgical procedures to excise mesh, and surgery to divide vaginal adhesions in 2018. It was reported that she experienced a steroid injection and left pudendal nerve block. Other procedure is captured in separate file. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SOMERVILLE
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key9981688
MDR Text Key191007456
Report Number2210968-2020-03225
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2020 Patient Sequence Number: 1
-
-